FDA Drug recall D-0283-2019

Clopidogrel Tablets, USP, 300 mg, 30 (5 x 6 unit-dose) count blister pack, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Srika…

• FDA Drug
• Class II
• terminated
• Published 2018-11-28

On 2018-11-28 the FDA classified a Class II recall of Clopidogrel Tablets, USP, 300 mg, 30 (5 x 6 unit-dose) count blister pack, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Srika… by Dr Reddy S Laboratories, citing failed Dissolution Specification: Out-of-Specification results were observed for dissolution at 18th month stability testing.

Read the official FDA Drug notice

Product

Clopidogrel Tablets, USP, 300 mg, 30 (5 x 6 unit-dose) count blister pack, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Srikakulam - 532 409, India, NDC 55111-671-31

Reason

Failed Dissolution Specification: Out-of-Specification results were observed for dissolution at 18th month stability testing.

Identifiers

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Other recalls by Dr Reddy S Laboratories

• Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-90…
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• Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL), 25 x 10 mL Multiple-Dose Vials, For Intravenous or Intramuscular use, Rx…
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• Omeprazole Delayed-release Capsules, USP, 20mg, 1000-count bottle, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally -…
  FDA Drug · Class II · 2025-07-23 · Dr Reddy S Laboratories
• Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg/100 mL (10 mg/mL), 1 x 100mL, Rx Only, Manufactured by: Gland Pharma Limited, Hyd…
  FDA Drug · Class I · 2025-04-23 · Dr Reddy S Laboratories
• Javygtor (sapropterin dihydrochloride) Tablets 100mg, 120-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ…
  FDA Drug · Class III · 2024-12-18 · Dr Reddy S Laboratories

All Dr Reddy S Laboratories recalls

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0283-2019%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.