FDA Class II Recall: ENALAPRIL MALEATE by JB Chemicals and Pharmaceuticals Ltd

Key facts

What this classification means

FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. In this case, the recalling firm is JB Chemicals and Pharmaceuticals Ltd and the affected product is described in FDA's record as: Enalapril Maleate Tablets, USP, 20 mg, 1,000-count bottle, Rx only, Manufactured by: Unique Pharmaceutical Laboratories (A Div. of J.B. Chemicals & Pharmaceuticals Ltd.), Mumbai 400 030, India, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC (additional items listed in FDA's full record). FDA's stated reason for the recall is: Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test. The recall is tracked under FDA recall number D-0520-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do. Recall status can change while FDA and the recalling firm continue corrective actions, so checking the firm's own notice for the most current guidance is recommended.

What consumers should do

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Specifically, check whether the product in your possession matches the description on file with FDA -- Enalapril Maleate Tablets, USP, 20 mg, 1,000-count bottle, Rx only, Manufactured by: Unique Pharmaceutical Laboratories (A Div. of J.B. Chemicals & Pharmaceuticals Ltd.), Mumbai 400 030, India, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC (additional items listed in FDA's full record) -- and the recall number D-0520-2026. If it matches, stop using or distributing it and contact JB Chemicals and Pharmaceuticals Ltd or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice.

JB Chemicals and Pharmaceuticals Ltd’s FDA history

Argus HQ has recorded 2 total FDA actions tied to JB Chemicals and Pharmaceuticals Ltd: 0 warning letters, 2 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

How serious is this recall?

FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote.

What should someone who has this product do?

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Check the product against FDA's description (Enalapril Maleate Tablets, USP, 20 mg, 1,000-count bottle, Rx only, Manufactured by: Unique Pharmaceutical Laboratories (A Div. of J.B. Chemicals & Pharmaceuticals Ltd.), Mumbai 400 030, India, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC (additional items listed in FDA's full record)).

Has JB Chemicals and Pharmaceuticals Ltd had other FDA recalls or enforcement actions?

Yes. Argus HQ has recorded 2 total FDA actions tied to JB Chemicals and Pharmaceuticals Ltd, including 2 recalls and 0 warning letters.

What is the FDA recall number for this event?

FDA recall number D-0520-2026.

Related enforcement actions

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